Professionalization in Clinical Research and How New Investigators Can Adapt

Professionalization in Clinical Research and How New Investigators Can Adapt

Dr. Kingsley was interviewed by Dan Sfera, The Clinial Trials Guru, at the 2019 DIA Conference in San Diego, California.

Welcome back to the Clinical Trials Guru. I’m with Dr. Kingsley at this tiny conference in San Diego called DIA. You might’ve heard about it. Dr. Kingsley has been featured on the show before on the podcast. He has his own podcast, his own YouTube channel, and he’s a thought leader in this industry. So we’re going to get his thoughts and opinions on where the industry’s headed specifically as it pertains to research sites out there. So, Dr. Kingsley, thank you very much for coming on.

As we are heading into the next decade, what, how is the landscape changing for sites?
Research is getting harder. We all know that there’s no two ways about it. There’s ample data to say that – it’s not my opinion. It’s fact. Research is getting harder and that’s ultimately a good thing. It’s getting harder for good and bad reasons. It means that you can’t dabble in research any longer and be successful in research. So, the fact that trials are getting harder and that it’s a risky industry will drive a phenomenon called professionalization. It means that research sites and researchers have to professionalize. The days of being an interventional cardiologist and then dabbling in one trial when you don’t really know what you’re doing? Those days will come to an end, and that’s a good thing ultimately for the industry. It’s a good thing, but it means that as research sites, we have to begin to invest in education, in process, in infrastructure, in order to be able to succeed in the future.

When do you think those days are coming to an end? Because it’s still not too late for that novice investigator to get started. You’re saying he or she has a little bit of leeway until this professionalism takes over.
I think it actually started a while ago and we’re in the process of evolution. This professionalization is something that happens in every industry. It happens in healthcare. So we’re all in health care, right? If you think about it, there was a time several decades ago, there was no such thing as an emergency medicine doc. There was no such thing as an emergency medicine fellowship. You were a family physician or or an internal medicine doc and you were interested in emergency health care and so you worked in the ER. But complicated environment becoming more complicated, right? The complexity of the patient coming into the ER was going up. The risk of human death was going up and that’s what has then generated the positive move where people started saying, “we’ve got to be professionals at emergency medicine.” The same exact process happened as an intensivist, people that take care of ICU patients. The same thing happens everywhere. That’s what we’re in the midst of in clinical research today. Complexity is going up and risk is high. That’s exactly the right ingredients for professionalization – where in another 10 or 20 years we’ll look back and we’ll be talking about the days when you could not know what you’re doing and yet convince a company to give you a research trial.

So you think that’s going to end?
Of course it will. Now there’ll be a mechanism to get in, but the mechanism to get in will require a hurdle, right? You can’t just decide to be an emergency medicine doc. You have to apply to and get involved in a fellowship program, a residency program, and go through all of that to prove you know what you’re doing. We’ll get the same kind of process going on in our world.

I like how you explained that as the complexity increases, risk increases the need for professionalism. But here’s the flip side of this. Much more opportunities are coming up because of this. So if the industry can create the infrastructure, which your company is playing a role in and mine is to some extent.

We need to get more of these research naive docs or even some of the established docs more professional, right? Is that what you’re saying?
And the thing is, if you do look at history and say, well, how did professionalization happened in other areas? It wasn’t really the docs that made it happen, it was the regulatory bodies and the insurance companies that made it happen. I think the same thing will happen here. So think about how we do research today. Today we are paid to give data to sponsors and CROs. High quality data and low quality data, we get exactly the same. We’re paid to give data. A site that invests in good technology to improve the quality of their data? They don’t get better budgets because they invested in the technology. And so in fact, there’s a counter-productive influence where you can be more profitable if you make very few investments and keep your expenses incredibly low. But that’s a setup where we can’t grow site behavior and grow professionalization. That’s something that I speak on frequently. Sponsors and CROs need to recognize this and begin compensating professional sites that are investing in infrastructure differently. And that produces a virtuous cycle. Today we’re in a vicious cycle where sites are prevented – financially disincentivized – to invest in infrastructure.

Most of the people watching or listening tend to be newer sites, and I’m always scaring them about, “hey, your landscape will change, and you’ve got to figure out where you fit in this whole ecosystem. But can you scare them as well? I want them to it from someone else.
Change is going to happen – I totally agree with Dan. Change is happening and is going to happen. You can’t avoid it. You’ve got two choices. You can lead the change or you can have the change happen to you. That’s it. People ask me why I became a CPI – a certified principal investigator – because today there’s nothing in it for me. I don’t get better study awards. I don’t get different contract and budget terms because I’m a CPI. My answer is because somebody has to start. There’s a virtuous cycle once you get a critical mass. And so it happened with CRCs and it happened with CRAs. Once you’ve got a critical mass of CRCs to become CCRCs, the value of CCRCs went up. Same will happen with CPI. So I would advise you to invest in infrastructure. There’s good data today. Peer-reviewed, evidence-based, statistically significant data to show that CPIs enroll better and perform better. They have fewer 483s, they have higher quality data, and they enroll better on contract terms than non-CPIs. So, as we get a critical mass of CPIs, what will happen is the industry will start to awards CPIs more trials than a non-CPIs, and they will start treating them differently. The same is true with investing in your infrastructure as a research site. Eventually if you don’t invest in infrastructure, you will lose study awards. It’s going to happen. So you can either wait for it to happen to you or you can help lead the way by investing in infrastructure and then pushing those boundaries in your contract and budget terms. Talk to sponsors about why they should treat you differently because of your investment. That’s how we will move the industry forward.

And now to scare you even more, all this was without even discussing virtual trials. What about a landscape where they don’t need you?
So, when you think about it, decades ago pharmaceutical companies began going direct to patient. Before that, they had never marketed direct-to-patient, they marketed to doctors. Doctors were a barrier in their ability to get at the patient. And so what eventually they did was they went around the doctor and they begin to market direct-to-patients to influence patients to talk to their doctors themselves. We’re seeing the same thing in our industry today. Sites are underperforming and so it’s just natural that sponsors begin to say, “how do we go around the site? How do we go directly to the patient?” And that’s what virtual is. Now virtual won’t completely eliminate the sites. It will eliminate a lot of what today’s sites do. As trials go direct-to-patient, virtual can’t happen in every research trial, but it can happen in a ton of them. And as it happens, you can end up with a principle investigator who’s the principal investigator for an entire state and very little need for brick and mortar. As that happens, brick and mortar sites are going to have to evolve.

This is why I love interviewing you as we get a glimpse into the future. What do you think about hybrid trials? I think there’s a lot opportunity there.
I hate them. Here’s why. In brick and mortar, all the patient visits are in a physical facility. In true virtual, all the patient visits are brought to the patient in the patient’s home. Hybrid is the industry saying, “well maybe we’ll just do a little bit of both – some of the visits are in the person’s home and some of the visits are in the office.” And here’s why it fails. I’m not saying that a hybrid trial will fail, but the economics fail. In a true virtual model, sites will be paid less per patient, per visit and investigators will be paid to interpret a physical exam but not to do a physical exam. And investigators will be paid to interpret the labs, but they don’t have to do the phlebotomy any longer. So the site budget is smaller on a per patient, per visit basis. The economics only work if you make it up in volume. In brick and mortar, I’m really only pulling from a very small radius around a brick and mortar office. Patients are only willing to drive so far. In true virtual, I can be a principal investigator for an entire state. Now I can make up the smaller budget in volume of patients. In hybrid, if I’m asking the patients at all to come to my office, I’m again pulling from a very small radius. So, if you can’t make it up in volume, your revenues is functionally going down in hybrid trials. That’s why I dislike hybrid.

So the business model of hybrid doesn’t make sense. It eliminates basically the value of virtual trial by having a broader target.
It still produces value for the patient. Hybrid still allows you to do some of the visits in the patient’s home. It’s still value to the patient, but the economics breakdown for the site in that year study budget will be lower in a hybrid model, because you’re not being paid to do all of the phlebotomy and those kinds of things. And you’re not able to make it up in the volume of patients. There were a couple of other really interesting ideas I’ve been having with sponsors on this topic on how you could do hybrid and yet still make it happen.

So with virtual trials, it seems like there will be less of a need for research naive physicians.
Yes. There are too few investigators in the world. You look at the Center for the Study of Drug Development and the metrics that Ken Getz puts out every year and the 51% churn rate of naive physicians. They signed their first 1572 and they never signed a second (the one and done’s). The only way you can continue to run your research pipeline is to continue to talk new doctors to get involved in research. We have too few experienced investigators. There are, I think, single digit percentages of physicians that have ever done more than seven research trials. And that’s horrible. It takes seven trials just to begin to know what you’re doing and until you’ve done a hundred trials, you don’t really feel comfortable with what you’re doing. I remember when I was in med school, a professor said it takes 10 years before you start feeling comfortable. Ten years post residency is when you’ll really hit your stride. It’s probably the same in research. It’s all that different, which means we need to get more physicians to be long term successes in research. Virtual allows us to pick the best of the best, experienced investigators because you don’t need 300 investigators to cover the country, you only need 50. If you have 50 investigators, one in every state, you’ve covered the entire nation.

So if your research naive, this is a call to action – get in now, get in this next decade. Things happening now.
And you become experienced and show that you know what you’re doing and you’re a longterm success and as virtual takes hold, you’ll end up with the opportunity to be an investigator covering your entire state or multiple states for that matter.

Now you go to way more of these conferences than I do and you speak at all of them. Is this topic high on big Pharma’s priority list. Like let’s get the trials, let’s get 50 experience PIs, and et’s forget about all these research naive PIs that we’re relying on now because they have the patients. Is this high on their list of priority?
I would say no to the way you asked the question. Is it a topic that is growing? Absolutely. A few years ago there were no virtual clinical trials conferences and then they started growing. And now they are numerous. I’m speaking at four this year – conferences that are dedicated to nothing but virtual clinical trials. The audience size is growing. The sponsors that are sending people and attending these are growing. There is a massive investment happening in virtual virtual is going to happen. Is it high on their priority list? I would answer your question as no because they do have a lot of other things going on today. I think they recognize it is coming. They recognize they need to invest in it today and only the early adopters are pushing forward and doing virtual trials today. They are happening today. Most of our industry, we are slow to adopt, right? Most sponsors are still saying maybe next year, but it’s coming.

You guys are lucky you’re hearing this and watching this early. Once you start hearing the increases in frequency of these conversations then you’re going to know. This is the way things are headed. You don’t really hear any more about risk based monitoring because that kind of got integrated into monitoring plans. So you’re going to hear less about virtual trials at some point, too, because it’s just going to be the norm.

So pay attention before it’s too late is the takeaway message. Dr Kingsley, thank you very much. Where can people find you on the Internet, website, all that stuff?
So I’m everywhere – Linkedin, Facebook, Instagram, Youtube. My podcast is Riding in Cars With Researchers and my website is iacthealth.com. Reach out to me. I’d love to have these conversations because my motivation is to improve the industry. That’s why I speak at conferences. The only reason I’m willing to get on a plane and go fly to these conferences and speak is because I want to help us improve the industry and professionalized research site behavior.